The US Drug Enforcement Administration (DEA) voted today (Aug 21) to move forward with rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II drugs. Schedule II medications are considered to be the most potentially harmful and open to abuse.

In addition to containing hydrocodone, HCPs also contain nonnarcotic substances such as aspirin or acetaminophen. Although hydrocodone by itself is classified as a schedule II drug, HCPs have been in the schedule III classification ever since the Controlled Substances Act (CSA) was first passed by Congress back in 1971.

"Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS,...the DEA finds that these facts and all other relevant data constitute evidence of potential for abuse of HCPs," write the DEA in their final rule.

"As such, the DEA is rescheduling HCPs as a schedule II controlled substance under the CSA," they add.

Substantial Feedback

HCPs are currently approved for marketing for the treatment of pain and for cough suppression.

The DEA published its formal proposal in February and asked for feedback, which could be given until April 28. The organization received 573 comments, of which 52% supported the recommended rescheduling, 41% opposed, and 7% did not voice a definitive opinion.

Patrick Morrisey, the attorney general from West Virginia, the state with the highest per capita rate of prescription drug overdoses in 2013, was among those who wrote in support of the rescheduling.

"This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers, it is necessary to combat the drug abuse epidemic that is destroying so many...communities," wrote Morrisey.

"Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl," he added in a release.

Also falling under the schedule II classification are illegal substances, such as methamphetamine and heroin, and prescribed medications, such as dextroamphetamine sulphate (Adderal, Teva Pharmaceuticals).

Once the final rule goes into effect, anybody who handles HCPs will be subject to the CSA's schedule II regulatory controls. This will include "administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engaging in research, conducting instructional activities, and conducting chemical analysis" of these substances.

In addition, any individual who handles or desires to hand HCPs will need to register with the DEA.

The final rule will be published in the Federal Register on August 22, 2014.

A week before he died, the 15-year-old honors student had taken an illustrated book to pastures near his Frisco home looking for psychedelic mushrooms. He didn’t find any, so he tried what he thought was LSD on Dec. 14. Convulsions began within an hour after he ingested 25I, a synthetic hallucinogen more potent than LSD. The Collin County medical examiner ruled that his death was connected to the drug. In what appears to be a growing problem, three more overdoses possibly linked to 25I were reported in McKinney last weekend. They appear not to have been fatal.

Efforts to criminalize emerging designer drugs in Texas fell flat in the most recent legislative session, making it more challenging for law enforcement agencies to crack down on the problem.

Nationally, at least 19 deaths have been linked to a set of synthetic drugs known as the NBOMe compounds, including 25I, according to the Drug Enforcement Administration. The users ranged from 15 to 29 years old. Texas Poison Control Network has tallied 25 calls related to NBOMe since 2012. Six came from the Dallas-Fort Worth area.

Stymied in Austin

In November, the DEA temporarily added three NBOMe drugs to Schedule I. In February, the Department of State Health Services added three NBOMe compounds to the state’s list of controlled substances. The temporary move allows prosecutors to pursue criminal charges, but only misdemeanors, regardless of the amount of the drugs.

Though the state banned K2 in 2011, other kinds of “fake pot” have surfaced since. And if the chemistry is slightly different from what’s in the law, dealers can avoid prosecution.

Law enforcement and public health officials said Huffman’s bills would address that problem by outlawing certain designer drugs and other compounds with the same core chemical structure.

Dueling experts

Like the federal government, Texas has provisions to cover analogs — drugs that are substantially similar to some illegal substances based on their chemical makeup or effects on users.

For every case, prosecutors would have to prove in court that the compound in question was similar enough to an illegal narcotic.

“It comes down to a battle of the expert witnesses,” said Samms, who wrote to lawmakers in support of Huffman’s proposed legislation.

And some cases don’t even make it to court if law enforcement or health officials can’t trace a drug.

NMS Labs in Pennsylvania, which does forensic testing for medical and legal clients across the country, handled its first NBOMe case in 2012.

“They’re very potent, so it takes very little drug to have its effects,” toxicologist Donna Papsun said. “The challenge was creating a test with a low enough detection level so we could properly detect it in the fluids.”

The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule 10 synthetic cathinones into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). This action is based on a finding by the Deputy Administrator that the placement of these synthetic cathinones and their optical, positional, and geometric isomers, salts and salts of isomers into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities, and possess), or propose to handle these synthetic cathinones.
NOTE: The 10 substances are: 4-methyl-N-ethylcathinone ("4-MEC"); 4-methyl-alpha-pyrrolidinopropiophenone ("4-MePPP"); alpha-pyrrolidinopentiophenone ("α-PVP"); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one ("butylone"); 2-(methylamino)-1-phenylpentan-1-one ("pentedrone"); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one ("pentylone"); 4-fluoro-N-methylcathinone ("4-FMC"); 3-fluoro-N-methylcathinone ("3-FMC"); 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one ("naphyrone"); and alpha-pyrrolidinobutiophenone ("α-PBP").

The Drug Enforcement Administration is extending emergency controls for six more months on five chemicals used to make fake pot products.

The agency is working on permanently designating smokable herbal products containing the five chemicals as controlled substances. The DEA took emergency action a year ago, making it illegal to possess and sell the five chemicals or products containing them.

The agency says the extension will provide time to complete the steps to permanent controls.

The United States Drug Enforcement Administration (DEA) is using its emergency scheduling authority to temporarily control five chemicals (JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol) used to make “fake pot” products. Except as authorized by law, this action will make possessing and selling these chemicals or the products that contain them illegal in the U.S. for at least one year while the DEA and the United States Department of Health and Human Services (DHHS) further study whether these chemicals and products should be permanently controlled.